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Sensory Testing and Brain Imaging for Menstrual Cramps
N/A
Waitlist Available
Led By Laura Payne, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female aged 13-19 years
Be younger than 65 years old
Must not have
Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Awards & highlights
Summary
This trial will explore the connection between brain function, pain inhibition, and chronic pain in adolescent girls.
Who is the study for?
Adolescent girls aged 13-19 with regular menstrual cycles and period pain, who are right-handed, have a BMI of 35 or less, can read English, and have access to a smartphone or email. Parental consent is required for those under 18. Exclusions include severe mental health conditions, metal implants incompatible with MRI scans, chronic pain conditions like IBS, recent use of certain medications including stimulants and hormones.Check my eligibility
What is being tested?
The study examines the brain's response to menstrual and non-menstrual pain in teens using sensory tests and fMRI scans. It aims to identify biomarkers predicting the development of persistent or chronic pain from primary dysmenorrhea (period pain without an organic cause) over two years.See study design
What are the potential side effects?
There are no direct side effects from participating in this trial as it involves non-invasive testing such as Quantitative Sensory Testing and fMRI scanning. However, discomfort may arise from being in enclosed spaces during MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a female between 13 and 19 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience pelvic pain all month, not just during my period.
Select...
I am currently experiencing severe depression, bipolar disorder, panic disorder, or ADHD, or am being treated for these.
Select...
I have been diagnosed with a chronic pain condition like IBS.
Select...
I have had pelvic inflammatory disease or an STD in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in bodily pain from baseline to 12-months post baseline
Change in menstrual pain from baseline to 12-months post baseline
Conditioned pain modulation (CPM)
+6 moreSecondary outcome measures
Change in bodily pain from 12-months post baseline to 24-months post baseline
Pain
Change in gray matter volume from baseline to 12-months post baseline
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: fMRI and laboratory pain inductionExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quantitative Sensory Testing
2017
N/A
~950
Find a Location
Who is running the clinical trial?
Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,497 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,359 Total Patients Enrolled
Laura Payne, PhDPrincipal Investigator - Mclean Hospital
Mclean Hospital
1 Previous Clinical Trials
70 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a psychotic disorder in the past or present.You use alcohol, cannabis, or other illegal drugs every week.Your body mass index (BMI) is 35 or lower.I am a female between 13 and 19 years old.I have a condition like autism that might make it hard for me to understand the study.I experience pelvic pain all month, not just during my period.You have metal braces, retainers, or implants that can't be used with the MRI machine.You have had normal periods for at least 6 months.You use your right hand for tasks.I have access to a smartphone or email.Your periods usually come every 22 to 35 days.I haven't used oral contraceptives or hormones in the last 3 months.I don't have any recent illnesses or injuries that could affect my pain sensitivity or performance in tasks.I am currently experiencing severe depression, bipolar disorder, panic disorder, or ADHD, or am being treated for these.You are very scared of small, enclosed spaces.I have been diagnosed with a chronic pain condition like IBS.I have had pelvic inflammatory disease or an STD in the past.I haven't used stimulants or opioids in the last 3 months.My parent can give written permission for me to participate.I was diagnosed with an eating disorder in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: fMRI and laboratory pain induction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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